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Warning Letters | FDA Warning Letters Learn about the types of warning letters on FDA's website. FDA sends warnings to food firms selling CBD A comprehensive plan for segregation if you intend to manipulate (e.g., open, sample, weigh, transfer) any beta-lactam or potent compounds. A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. In March 2021, the U.S. FDA issued a Warning Letter to a Chinese manufacturer of over-the-counter (OTC) drug products called "Foshan Biours Biosciences Co., Ltd." due to significant violations of cGMP regulations for finished pharmaceuticals.. The Warning Letter goes back to an inspection from September 7 to September 9, 2021. Include a detailed CAPA plan that comprehensively remediates your firms documentation practices to ensure you retain attributable, legible, complete, original, accurate, and contemporaneous records throughout your operation. Your response is inadequate. You will see the overarching topics and we will drill down into the data to determine risk and priorities. Drugs from one API supplier used by your firm were listed on IA 99-32 for the suppliers conduct in delaying, denying, or limiting FDA inspections of foreign facilities or providing reasonable access to FDA's inspectional personnel. In addition, describe the steps that must be taken in your change management system before introduction of new manufacturing equipment or a new product. In the fiscal year 2022 (Oct. 2021 - Sept. 2022), a total of 42 Warning Letters were sent to medicinal product manufacturers, each explicitly describing the GMP deficiencies in connection with the paragraphs of 21 CFR 211. GMP Training, FDA 483, FDA Warning Letter - Are you ready for inspection? Warning Letters - Health Fraud | FDA May 10, 2022. A complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. An independent assessment of your facilities, equipment, processes, and materials to determine suitability for their intended use in the manufacture of all drugs. We acknowledge your commitment to suspend manufacturing of drugs at this facility. You did not routinely identify isolates recovered during environmental monitoring of your aseptic processing areas where your sterile drug products are filled. During our inspection, our investigators observed specific deviations including, but not limited to, the following. o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices All drug products from (b)(4) have been listed on FDA IA 66-40 since (b)(4), and they remain on import alert at this time. Viewing the right FDA WL is helpful, analyzing 100K+ enforcement documents is powerful. Training and Continuing Education (2) Vaccines, Blood & Biologics (15) Facet Topic Area. Data integrity citations are often closely linked with other breaches of current GMP (cGMP), such as failure to investigate non-conformances/deviations, failure to document CAPAs and review their effectiveness, and failure to devote adequate resources to personnel training, Supervision, and SOP updates. In your response, you provided a recently established procedure for receipt, storage, and release of your incoming materials. o qualified individuals perform training Your response is inadequate because you did not comprehensively address the environmental and personnel monitoring deficiencies and the effect of such deficiencies on the quality of distributed drug products. Your firm failed to ensure that all personnel are trained as appropriate. The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Our training classes are based on Adult Learning Principles that are powered with active participation. First, business owners/Managers must devote adequate resources to data integrity/data governance assurance measures. Enter your email address to subscribe to this blog and receive notifications of new posts by email. Increased product demands also prove challenging to Regulators and their GMP compliance inspectors. Rapid antigen tests (RATs) are in high demand across the globe, particularly as new variants make their way into both vaccinated and unvaccinated populations. Effective FDA 483 & Warning Letter Response - Training The GMP violations described in the 23 Warning Letters can be grouped as follows: This compilation shows: Most violations of basic GMP rules are closely related to the quality unit's failure to take responsibility. A quick look at the FDA's warning letters site led me to this: amazing how deeply they can go thank's for sharing. In March 2021, the U.S. FDA issued a Warning Letter to a Chinese manufacturer of over-the-counter (OTC) drug products called "Foshan Biours Biosciences Co., Ltd." due to significant violations of cGMP regulations for finished pharmaceuticals. In response, you stated you would revise your procedure for microbial identification to require the the identification of all isolates from your Grade A and Grade B areas, and documentation of the morphology and microscopic inspection of all other isolates. The company's answers dated 3 November 2021 regarding the complaints listed in Form FDA 483 were deemed inadequate by the FDA. You did not address the reasons for the lapse in oversight of your training program, and you did not provide a detailed plan for assessing the effectiveness of your training. Your firm manufactures and aseptically fills (b)(4) drug products for distribution to the U.S. You did not establish the suitability of the sterility test method used for final release testing of (b)(4) of your finished drug products. The assessment and CAPA, including any recommendations from the independent review, should include justification of sampling locations, frequency of sampling, alert and action limits, adequacy of sampling techniques, and the trending program. See FDAs guidance document, Sterile Drug Products Produces by Aseptic Processing Current Good Manufacturing Practice, to help you meet the CGMP requirements when manufacturing sterile drugs using aseptic processing, at https://www.fda.gov/media/71026/download. Syntec Pharma Corp - 612765 - 07/06/2021 | FDA Search | FDA - U.S. Food and Drug Administration We acknowledge your commitment to cease production of drugs for the U.S. market. o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products. So as we start the 3rd year of living with a pandemic, we want to reiterate the importance of data integrity on product quality, safety, and efficacy; as well as its impact on supply chain stability and counterfeit prevention. FDA Warning Letter: Testing into Compliance using Unvalidated Test Agila Specialties Private Limited Warning Letter, FDA Warning Letter on Medical Device Reporting Interpretation, Jubilant HollisterStier General Partnership [warning letter]. However, our review of your records found that you charged your customer for repackaging lot (b)(4)of Lomustine, a cytotoxic chemotherapy agent. The European Qualified Person - What's it all about? When demand exceeds available supply and when shipping delays impede typical pharmaceutical supply chains/distribution channels counterfeit products become an increasing concern. Review current guidance on Data Integrity, Computer Systems & 21 CFR Part 11 guidance, Review current FDA 483 & Warning Letters, Module 105 Contamination Control Principles & Practices (Non-sterile products) 4-hour class, Types of contamination physical, chemical, microbial, Gowning & Personal Protective equipment/PPE, Material, process and personnel flow, Module 106 Self Inspections/Internal Quality/Compliance Audits and Assessments 2-hour class, Regulatory Expectations on Self Inspections/Assessments, Training & Qualification Requirements, Module 107 Supplier Quality Management 4-hour class, Regulatory Requirements on Supply Chain Excellence, Qualification & Disqualification criteria, Module 108 Quality Management System 4-hour class, Quality Council/Management Reviews, Quality Manual/Quality Manual/SOP Structure, Module 109 Regulatory Affairs Best Practices (Each module is approximately 45 90 Minutes), Introduction to FDAs Regulatory Framework, Introduction to FDA Guidance Documents, Writing and responding to the FDA, Telephone conference with the FDA, Managing Regulatory Changes & Supplements, Complaint Systems/Adverse Event Management, Drug Product Recalls & Product Withdrawal, Module 201 Quality Assurance (2-Day class), Corrective & Preventive Action Program, Module 202 (A) Laboratory Controls Quality Control Chemistry & Physical Laboratory Customized per client needs assessments, Equipment set-up, cleaning, maintenance, calibration, Laboratory Records Management (Forms/Logbooks, Laboratory Computer System (21 CFR Part 11), Data Integrity for Laboratory/Electronic Data/Applications, Module 202 (B) Laboratory Controls Microbiology Customized per client needs assessments, Microbial Growth Media/Preparation, sterilization, growth promotion), Microbial Sampling (water system, environmental, product), Laboratory Cleaning & Sanitization, Reporting Discrepancies & Deviations, Module 203 Production & Process Controls Customized per client needs assessments, Good Housekeeping, Cleaning and Sanitization, Environmental Control & Monitoring, Good Documentation Practices for Production Personnel, Understanding QA Roles & Responsibilities, Module 204 Facilities & Equipment Customized per client needs assessments, Environmental Control, Monitoring, Site Mapping, Cleaning, Sanitization, Contamination Control, Pest Control, Module 205 Packaging & Labeling Controls Customized per client needs assessments, Control of components, closures, drug product packaging & labeling, Executing Packaging Batch Records, Rework and re-dress of packaged product, Module 206 Warehouse & Distribution Customized per client needs assessments, Warehousing (Manual and Automated storage/retrieval systems, Environmental Control and Monitoring, Module 207 Material System Customized per client needs assessments, Material usage and reconciliations, Use of Inventory Management Systems, Module 301 Aseptic Processes 2 Day class, Gowning and Sanitary Practices and qualifications. How does water quality for injectable pharmaceuticals (known as Water For Injection, Read More Pharmaceutical Water For Injection (WFI)Continue, Lean manufacturing and just in time shipping strategies means medical supply chain risks are an ever-present phenomenon. Warning Letters | FDA Warning Letters Learn about the types of warning letters on FDA's website. Your receipt in interstate commerce of adulterated drugs and the delivery or proffered delivery thereof, is a violation of section 301(c) of the FD&C Act, 21 U.S.C. FDA Warning Letters The U.S. Food and Drug Administration (FDA) has made a number of different non-compliance oversight determinations at institutions over the last several years. *The FDA defines health fraud as the deceptive promotion, advertising, distribution, or sale of a product represented as being effective to prevent, diagnose, treat, cure or lessen an illness or condition, or provide another beneficial effect on health, but that has not been scientifically proven safe and effective for such purposes. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211). The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Data Integrity Problems as Main Topic of an FDA Warning Letter FDA Warning Letter & Inspection Observation Trends [Updated 2023] Specify what you have done since our inspection to correct your violations and to prevent their recurrence. 381(a)(3). o For highly potent API, provide an appropriate CAPA that ensures containment for these API to prevent cross-contamination and other safety hazards. QA releases batches prior to review of manufacturing documentation. Before initiating formal enforcement action, FDA, by issuing warning letter, gives an opportunity to the firm to take voluntary corrective action. You failed to identify the risks associated with the drugs you handled, and to provide an appropriate corrective action and preventive action (CAPA) plan to ensure the remediations necessary to prevent cross-contamination and mix-ups. The warning letter of ONBO - Why FDA require identification of 510(k) ownership? After you receive this letter, respond to this office in writing within 15 working days. o A complete and final review of each batch and its related information before the QU disposition decision The studies should include, but not be limited to: You also failed to provide details of your supplier qualification program. We note that you have discontinued production of over-the-counter (OTC) (b)(4)drug products intended for distribution to the United States (U.S.); however, you failed to have adequate interim measures in place for products currently on the market within expiry. Your plan to improve oversight of your training program. A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. Similarly, you also failed to address the potential impact from your failure to ensure the suitability of the in-process bioburden test. Good documentation practice and adequate and effective testing methods and procedures are key aspects of cGMP regulations and need to be considered to maintain cGMP compliant systems throughout the product life cycle. If testing yields an OOS result, indicate the corrective actions you will take, including notifying customers and initiating recalls. Your response is inadequate. Matters described in FDA warning letters may have been subject to subsequent. Yet data integrity takes on increased importance during a pandemic, primarily because: Also, the recent increase in FDA Warning Letters on data integrity issues are not stand alone warnings. Per your procedure, SOP for Microbial Identification Management (QS-508), recovered isolates are grouped according to visual morphology. falsification of testing data or repeated testing until pass, Failure to adequately document deviations and CAPAs, Failure to ensure computer system log-ins are secure and never shared, Failure to restrict system administration rights, Failure to validate computerised systems or software upgrades, Failure to conduct data audits in a timely manner and/or as scheduled, Issues with signatures including written signatures and electronic signatures, Lack of data governance (e.g. The site is secure. In 2020, when SARS-CoV-2 rapidly made its way across the globe, In 2021, when the virus mutated to a Delta variant, followed by an Omicron variant (and other variants of concern), In 2021 and 2022, when new medicines were approved, resulting in billions of vaccine doses and PCR tests being administered to protect our populations). See FDAs guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download. This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. FDA Warning Letter: Testing, Stability Program and Quality Oversight developer or contract manufacturer? The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Samchundang Pharm Co., Ltd., FEI 3008425092, at Hyangnam Pharmaceutical Industries Complex, 71. To view the complete list of violations and the conclusion given by the U.S. FDA, please see the Warning Letter toFoshan Biours Biosciences Co., Ltd. Latest FDA inspection trends: common audit, Read More Top 10 GMP Audit Citations: FDA & TGA InspectionsContinue, What is Water For Injection (WFI)? QA does not ensure that the test methods of the contract laboratory are validated. Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP. Don?t Confuse ?Made In USA? On (b)(4) received a warning letter from the FDA for failure to comply with CGMPs. Samchundang Pharm Co., Ltd. - 599255 - 05/13/2020 | FDA Warning Letter adressed to owner/operator or facility? After you receive this letter, respond to this office in writing within 15 working days. Why data governance measures are essential to protect product quality, brand reputation, and supply chain security. Cannabis), GMP Courses & Conferences on Site (in hotels), Online Training & Webinar Recordings by topic. Include appropriate design and control provisions related to equipment, air systems, rooms, and procedures. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 2. Demand for medicinal products, medical devices (e.g. If your firm intends to resume drug manufacturing for the U.S. market, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. There have been over 9 billion covid-vaccine doses administered as of early January 2022. With Patriotism, Gilead plant joins the FDA's "warning club", Where you can read other companys' 483 FDA Warning Letters, IMDS Warning - Chromate Filming of Zinc Plating, FDA Global Clampdown: 8 Warning Letters - Failing to Register Plants, Appropriate Statistical Methods to set up an Alert/Warning Limit, Quality Assurance and Compliance Software Tools and Solutions, FDA issued Warning Letters to Beckman Coulter - 2011, FDA issues Warning Letters for misleading advertising of Lap-Band, FMEA Severity 9 &10 - Example of "with warning? South Korea. 351(a)(2)(B). In response to this letter, clarify whether you intend to conduct any operations at this facility in the future. In response to this letter, provide a comprehensive, independent and retrospective review of personnel and environmental monitoring data since 2018. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion. Review of 21 CFR 210 & 211 (Drugs) Each subpart will be reviewed, Integrating scientific principles for sustainable compliance, Modern Concepts Process Analytical Technology (PAT), QbD, Six-Sigma, Lean and Process Capability Studies, Regulatory Requirements for handling discrepancies. Take a moment to look at FDA's website Warning Letters which show that lack of or inadequate training or incomplete training records is common warning letter deficiencies. For a better experience, please enable JavaScript in your browser before proceeding. In relation to the observations mentioned above, the U.S. FDA now expects, for example, comprehensive assessments of procedures and methods as well as a list of the amended SOPs. Poor Documentation Practice caused U.S. FDA Warning Letter . PDF Data Integrity Case Studies - Parenteral Drug Association Suitability testing establishes that contamination, if present, will be detected. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion. FDA considers the expectations outlined in ICH Q7 when determining whether API are manufactured in conformance with CGMP. You are responsible for investigating and determining the causes of any deviations and for preventing their recurrence or the occurrence of other deviations. All drug products from (b)(4) have been listed on IA 99-32 since (b)(4), and they remain on import alert at this time. This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. It is important to set action limits accordingly. United States. Current FDA 483 Observations and Warning Letters Review - ComplianceOnline o job functions and training needs are reviewed on an ongoing basis to monitor whether staff competencies are robust We reviewed your November 14, 2019, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. Furthermore, you kept weed killer, engine antifreeze coolant, and dry wall repair products in the same room where you stored your API and packaging components. Another FDA Warning Letter for inadequate CAPAs You must log in or register to reply here. If you have questions regarding the contents of this letter, please contact Nancy Scheraga and Emmanuel Ramos, Compliance Officers, at Nancy.Scheraga@fda.hhs.gov and Emmanuel.Ramos@fda.hhs.gov. During the inspection, you stated that the laundry detergent (b)(4) was used to clean the ventilation hood, utensils (stainless steel spoons), and balances. PDF FDA Warning Letters - Research Employer Warning Notice a Controlled Document? 510(k) Issuance & Warning Letter - to spec. In April 2022, the U.S. Food and Drug Administration (FDA) published a Warning Letter dated March 14, 2022, to an American drug manufacturer. Before sharing sensitive information, make sure you're on a federal government site. Results of the retrospective sterility testing of all reserve batches of U.S. marketed drug products within expiry as of the date of this letter. A risk assessment of the U.S. marketed batches of drug product in distribution and within expiry as of the date of this letter. Division I, An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Inspections, Compliance, Enforcement, and Criminal Investigations, https://www.accessdata.fda.gov/cms_ia/ialist.html. Failure to perform repackaging, relabeling, or holding of API under appropriate CGMP to avoid mix-ups and loss of API identity or purity. o A determination of whether procedures used by your firm are robust and appropriate Our training classes are based on adult learning principles and conducted by qualified and experienced industry professionals. More specifically: Complaint Letter, Coffee Break and Water Cooler Discussions, Warning about Deltronic Gage Pins - The "Certification of Accuracy" document, General Measurement Device and Calibration Topics, IMDS - Help (Common Warning and Error Fixes), RoHS, REACH, ELV, IMDS and Restricted Substances, IMDS Warning Polymer Material Two Substances. Your written notification should refer to the Warning Letter number above (#612765). PDF Lessons from pharmaceutical laboratory related FDA warning letters - Huber Your firms executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance. o Swabbing locations for areas that are most difficult to clean 351, Hyoryeong-ro Our training modules are customized based on our client needs, and include highly interactive sessions. Drugs from two of the API suppliers used by your firm were listed on import alert IA 66-40 for the suppliers failure to conform to current good manufacturing practice within the meaning of section 501(a)(2)(B). Correct any deviations promptly. Quick LinksGMP NewsGuidelinesTrainingGMP Inspection DatabasesMembers AreaContactJoin ECA, Imprint | Privacy Policy | Cookie Settings | Sitemap | GTB, Herbal Medicinal Products (incl. Inadequate environmental and personnel monitoring practices may obscure the type and level of microbiological contamination in your aseptic processing facility. The .gov means its official.Federal government websites often end in .gov or .mil. Director Search for Warning Letters: Recently posted Warning Letters and an archive dating back to 1996, An official website of the United States government, : FDA Warning Letters Archives - Ofni Systems To learn more, download our current training brochure, and get a free quote. Center for Drug Evaluation and Research, An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Inspections, Compliance, Enforcement, and Criminal Investigations, Samchundang Pharm Co., Ltd. - 599255 - 05/13/2020. Unresolved deviations may also prevent other Federal agencies from awarding contracts. I wanted to share this here because industry have the tendency of hiring QA/Regulatory personnel without the adequate science qualification and hence it effects the quality of the product in the chain. Besides other failures listed in the FDA Warning Letter the firm failed to have an adequate release testing procedure of the respective product as well . The MHRA have a similar service in the UK. FDA Sends Warning Letters to Multiple Companies for Illegally Selling Adulterated Dietary Supplements, Uplift Max and Shred Her Max, which were cited in the FDA, FDA issues warning letters to two breast implant manufacturers as part of ongoing efforts to protect patients, Today, the U.S. Food and Drug Administration issued, ement-and-criminal-investigations/enforcement-story-archive/, FDA and FTC Send Warning Letters to Five Companies for Illegally Selling Dietary Supplements Claiming to Treat Infertility, (FDA) and the Federal Trade Commission (FTC) issued, FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements, FDA Sends Warning Letters to 10 Companies for Illegally Selling Dietary Supplements Claiming to Treat Depression and Mental Illness, The U.S. Food and Drug Administration (FDA) today posted, FDA Issues Warning Letters to Three Companies for Selling Unapproved New Drugs for Mole and Skin Tag Removal, Food and Drug Administration announced it issued three, Warning Letters and Civil Money Penalties Issued to Retailers for Selling JUUL and Other E-Cigarettes to Minors, in the FDA's history , the agency issued more than 1,300, Coronavirus (COVID-19) Update: FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk, /press-announcements/coronavirus-covid-19-update-fda-issues-, FDA and FTC Send Warning Letters to 10 Companies for Illegally Selling Dietary Supplements Claiming to Treat Diabetes, e-enforcement-and-criminal-investigations/enforcement-story/, FDA Inspection Blitz Leads to More Than 180 Warning Letters to Retailers for the Illegal Sale of Youth-Appealing Elf Bar and Esco Bars E-Cigarettes, s-announcements/fda-inspection-blitz-leads-more-180-, FDA Completes Initial Review of 95% of Non-Tobacco Nicotine Product Applications; Agency Has Issued Over 60Warning Letters to Manufacturers, Including for Products with a Submitted Application and Negative Action, As of Oct. 7, FDA has issued Refuse to Accept (RTA), FDA In Brief: FDA Issues Warning Letters to Jimmy Johns and a Sprout Distributor for Food Safety Violations, Today the U.S. Food and Drug Administration posted a, Statement from FDA Commissioner Scott Gottlieb, M.D., on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims; and the agencys ongoing concerns about kratom, ouncements/statement-fda-commissioner-scott-gottlieb-md-new-, d-criminal-investigations/compliance-actions-and-activities/, Tobacco Retailer Warning Letters - Overview, cco-products/retail-sales-tobacco-products/tobacco-retailer-, /animal-veterinary/compliance-enforcement/cvm-, Warning Letters Related to Food, Beverages, and Dietary Supplements, /medical-devices/industry-medical-devices/, /drugs/enforcement-activities-fda/sunscreen-, pections-compliance-enforcement-and-criminal-investigations/, FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice, and effective products for patients, the agency is sending, An official website of the United States government, For Federal, State, Local, Tribal, and Territorial Officials, Inspections, Compliance, Enforcement, and Criminal Investigations, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, Center for Food Safety and Applied Nutrition, Recalls, Market Withdrawals and Safety Alerts, https://www.fda.gov/food/cfsan-constituent-updates/fda-sends-warning-letters-multiple-companies-illegally-selling-adulterated-dietary-supplements, https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-two-breast-implant-manufacturers-part-ongoing-efforts-protect-patients, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/enforcement-story-archive/warning-letters-1999-2003, https://www.fda.gov/food/cfsan-constituent-updates/fda-and-ftc-send-warning-letters-five-companies-illegally-selling-dietary-supplements-claiming-treat, https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-two-breast-implant-manufacturers-failure-comply-post-approval-study, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/enforcement-story-archive/warning-letters-fy-1992-2001, https://www.fda.gov/food/cfsan-constituent-updates/fda-sends-warning-letters-10-companies-illegally-selling-dietary-supplements-claiming-treat, https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-three-companies-selling-unapproved-new-drugs-mole-and-skin-tag-removal, https://www.fda.gov/tobacco-products/ctp-newsroom/warning-letters-and-civil-money-penalties-issued-retailers-selling-juul-and-other-e-cigarettes, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-warning-letters-companies-inappropriately-marketing-antibody, https://www.fda.gov/food/cfsan-constituent-updates/fda-and-ftc-send-warning-letters-10-companies-illegally-selling-dietary-supplements-claiming-treat, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/enforcement-story/warning-letters-fda-center-fy-2002, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/enforcement-story-archive/warning-letters-fda-center-fy-2003, https://www.fda.gov/news-events/press-announcements/fda-inspection-blitz-leads-more-180-warning-letters-retailers-illegal-sale-youth-appealing-elf-bar, https://www.fda.gov/tobacco-products/ctp-newsroom/fda-completes-initial-review-95-non-tobacco-nicotine-product-applications-agency-has-issued-over-60, https://www.fda.gov/news-events/fda-brief/fda-brief-fda-issues-warning-letters-jimmy-johns-and-sprout-distributor-food-safety-violations, https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-warning-letters-fda-issuing-companies-marketing, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters, https://www.fda.gov/tobacco-products/retail-sales-tobacco-products/tobacco-retailer-warning-letters-overview, https://www.fda.gov/animal-veterinary/compliance-enforcement/cvm-warning-letters, https://www.fda.gov/food/compliance-enforcement-food/warning-letters-related-food-beverages-and-dietary-supplements, https://www.fda.gov/medical-devices/industry-medical-devices/letters-industry, https://www.fda.gov/drugs/enforcement-activities-fda/sunscreen-warning-letters, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/2018-warning-letters, https://www.fda.gov/news-events/press-announcements/fda-sends-warning-company-marketing-dangerous-unapproved-stem-cell-products-put-patients-risk-and.